MINUTES OF 318 th MEETING OF REGISTRATION COMMITTEE HELD ON 27-04-2011 AT 11.00 A.M. IN THE COMMITTEE ROOM NO-112, AT KRISHI BHAVAN, NEW DELHI.

The 318th meeting of Registration Committee (RC) was held under the Chairmanship of Dr. Gurbachan Singh, Agriculture Commissioner on 27-04-2011 in the Committee Room No. 112, Krishi Bhavan, New Delhi. Shri S.K.G. Rahate, I.A.S., Joint Secretary (M&T) & Plant Protection Adviser to the Government of India, Dr. D. Kanungo, Addl. DG, MOH&FW, New Delhi, Dr. T.P. Rajendran, ADG(PP), ICAR, New Delhi and Dr. Sushil K. Khurana, Addl. Plant Protection Adviser (CIB&RC) attended the meeting. Following Officers from the Secretariat of CIB&RC were also present:-

(i) Dr. Hari Prasad, Joint Director (Chem.)(ii) Dr. A.K. Sinha, Joint Director (PP)(iii) Dr. B.S. Phogat, Joint Director (WS)(iv) Dr. R.M. Shukla, Joint Director (Ento.)(v) Shri B.N. Jha, Deputy Director(Chem.)(vi) Dr. Subhash Kumar, Assistant Director (WS)(vii) Shri Dipankar Bhattacharya, Assistant Director (Chem.)(viii) Dr. Vandana Seth, Assistant Director (Chem.)(ix) Ms. Kamlesh Miglani, Assistant Director (Chem.)(x) Sh. S.K. Ghosh, Consultant (Packaging) &

Ex-Dy.Director (Packaging)(xi) Sh. S. K. Verma, Section Officer (CIR-IIB)(xii) Sh. D.S. Sehrawat, PPO(Packaging)

At the outset, the Chairman welcomed the members and experts of Registration Committee and requested APPA(CIB&RC) to take up the agenda, item-wise for discussions and the following decisions were taken by the RC:-

Agenda item

No.

Particulars of Agenda

1.0 Confirmation of minutes of the 317th meeting of the Registration Committee.

Minutes of 317th RC were confirmed.2.0 Follow up action on the decision taken by the Registration

Committee in its 317th meeting.

Noted with satisfaction.

2.1 Applications pending under various sub-sections of the

Insecticides Act, 1968.

Noted with satisfaction.

3.0 Government Business 3.1 Further clarification on the recommendations of Registration

Committee on the Final report of fresh review of Registration of products Acetamiprid Technical (Pride) and its 20% SP formulation, Chlorpyriphos 50% + Cypermethrin 5% EC (Nurelle) and Chlorpyriphos 10% Granule (Dursban 10% G).

Section 9 of the Insecticide Act, 1968 deals with the registration of pesticides by the Registration Committee of Central Insecticide Board (CIB), constituted under section 5 of the Act. The registration of pesticides is undertaken only after satisfying itself regarding efficacy of the insecticides and its safety to human beings, animals and environment. The registration certificates are issued to the manufacturers/importers/applicant under various sub-section of Section 9, depending on the timing of application or the type of application. It means that the applicant, who applies for the first time for Section 9, sub-section 3 registration, based on the requirement of data/information are granted registration that, whereas, the subsequent applications are granted, under section 9, sub-section 4 of the Act to such applicants, based on the strength of 9(3) certificates of the respective products.

In the instant case, M/s Dow Chemicals applied first, under section 9, sub-section 3 of the Insecticide Act for registration of Acetamiprid Technical and its 20% SP formulation. The registration was granted, after due satisfaction by the Registration Committee of CIB regarding their safety and efficacy. Subsequent certificates, under Section 9, sub-section 4, were issued to other applicants on the same analogy.

The decision of Registration Committee of CIB was made in the 315 th

meeting of 22nd February, 2011 for withdrawal / cancellation of registration certificates of M/s Dow Chemicals, in respect of Acetamiprid technical and its formulation, due to unethical practices adopted by this company in the process of registration of these two products and not due to any adverse technical aspects of these products. Since the Registration Committee of the CIB is satisfied on the efficacy to target pests as well as on the safety to human beings and animals of Acetamiprid Technical and its formulation, there is no

justification to completely eliminate the products from the country. It is noted that this is widely used in cotton crop of the country. It is also relevant to mention that no adverse impact of these products has been reported in agriculture from any other country, where they are registered. Accordingly, certificates of the registrants under section 9, sub-section 4 of these products, if any, will continue.

In the case of Chlorpyriphos 10% G, the unethical practice by M/S Dow Chemicals was amply proved for its cancellation of its certificate under section 9, sub-section 3. However, it was viewed that certificates of the registrants under Section 9, sub-section 4 of this product, if any, will continue. The Registration Committee of CIB is satisfied with its bio efficacy to target pests and also noted that there is no adverse impact of this formulation in agriculture.

In respect of Chlorpyriphos 50% + Cypermethrin 5% EC (Nurelle) formulation, the position of higher toxicity of the formulation over that of individual substances of this mixture formulation, unequivocally, made the Registration Committee of CIB to decide upon withdrawing certificates under section 9, sub-section 3 and that under section 9, sub-section 4 of the product.

3.2 Violation of Insecticides Act, 1968 by virtue of malpractices and misleading activities adopted by M/s Syngenta India Ltd., with respect of Emamectin Benzoate 5% SG in India-reg.

The Agenda was deliberated in detail and the Committee decided that M/s. Syngenta India Ltd. may be called for personal hearing.

3.3 Follow-up action 316th meeting of RC pertaining to Agenda Item No. 3.7 (Complaint received regarding registration of Bti Technical and formulation for import in respect of M/s Biotech International, New Delhi.

The Agenda was deliberated in detail and the Committee decided that M/s. Bio-tech International may be called for personal hearing.

3.4 Check list for submission of application for attestation of copy of already issued Certificate(s) or Registration.

Approved as per Annexure-I. The Committee also decided that attestation of copy of already issued Certificate(s) of Registration may be made within 15 days.

3.5 Report of Expert Group on chemicals having dual use-follow up of 313th meeting of RC regarding recommendations of Dr. C.D. May Committee report at S. No. 6.

The recommendations of the Expert Group were deliberated in detail and the Committee accepted the recommendations as under:-

1. A compound is included in the Schedule to the Insecticides Act, if it has insecticidal use activity. There is no provision under the Insecticides Act to remove the compounds from the Schedule. The reason being that when the compound has found to have insecticidal activity, whether it is used or not as Insecticide it will continue to possess insecticidal properties. Therefore, as per the provisions of the Act, as well as by logic, compound once included in the schedule, cannot be removed from it. Further if these insecticides are removed from the Schedule, the provisions of the Act shall not be applicable to them and these shall remain unregulated.

2. Regarding addition of miniscule quantity of compounds, which are included in the schedule to the Act, in the pesticide formulations as adjuvant, the group observed that some formulations like Allethrin plus PBO (Piperonyl Butoxide) are registered under the Act, wherein PBO which is included in the schedule to the Act is used as synergist and not as insecticide. The Group also noted that there are some applications pending in the Sectt. of CIB&RC for registration wherein substances included in the schedule to the Act are present in the chemical composition of pesticides formulation and claimed as Adjuvant. After detailed deliberations, the Group recommended that such cases should be considered on case to case basis wherein onus of submitting data/information to prove that the substance included in Schedule and present in the quantity in to the extent in chemical composition of pesticide formulations are safe and has function other than as pesticide, shall be of applicant. For this, applicant should submit laboratory data on bioefficacy with the same concentration as of the 2nd

and 3rd a.i., used as Adjuvant in the formulation. Further, these guidelines shall not be applicable where Herbicide or PGR has been used as 2nd and 3rd a.i. in the formulation as they may show efficacy in those miniscule quantity also.

3.6 Acceptance of test report from IIP which is “For Private Use only. Not to be use for publicity or litigation”.

The Agenda was deliberated in detail and the Committee decided that status quo may be maintained since it has been the practice since long. However, letter may be issued to the Director, IIP for further clarification as indicated in Agenda.

4.0 Export Cases4.1 List under section 9(3) Export of applications

The list of 5 products on page 76 of Agenda, is approved.

4.2 Ex-post-facto approval and consideration of application of M/s United Phosphorus Ltd., Mumbai under the category of Star Export for indigenous manufacturing of Cypermethrin 30% + Dimethoate 250 g/l EC under Section 9(3) for Export Only.

Approved.

5.0 9(3B) Cases5.1 Request of M/s Advance Bio-Tech Industries & Research Inputs

(India), Indore (MP) for 1st time extension of validity period of provisional certificate of registration of Pseudomonas fluorescens 0.5% WP for one year with commercialization.

Extension is approved for one year with commercialization from the date of issue of letter of extension.

5.2 Request of M/s Bio Agro Ferticons Pune (MS) for 1st time extension of validity period of provisional certificate of registration of Pseudomonas fluroescens 0.5% WP for one year with commercialization.

Extension is approved for one year with commercialization from the date of issue of letter of extension.

5.3 Request of M/s Prathibha Bio-Tech Hyderabad (AP) for 3rd time extension of validity period of provisional certificate of

registration of Pseudomonas fluroescens 0.5% WP for one year with commercialization.

Extension is approved for one year with commercialization from the date of issue of letter of extension.

5.4 Request of M/s Sai Agrotech Dadra Nagar, Yavatmal (MS) for 1st

time extension of validity period of provisional certificate of Registration of Trichoderma viride 1% WP for one years with commercialization.

Extension is approved for one year with commercialization from the date of issue of letter of extension.

5.5 Request of M/s Prathibha Bio-Tech Hyderabad (AP) for 3rd time extension of validity period of provisional certificate of registration of Trichoderma viride 1% WP for one year with commercialization.

Extension is approved for one year with commercialization from the date of issue of letter of extension.

5.6 Request of M/s Chaitra Agri Organics, Banglore for 2nd time extension of validity period of provisional certificate of registration of Trichoderma viride 1% WP for one years with commercialization.

Extension is approved for one year with commercialization from the date of issue of letter of extension.

5.7 Request of M/s Advance Crop Care (India)Pvt. Ltd., Indore (MP) for 1st time extension of validity period of provisional certificate of registration of Trichoderma viride 1% WP for one years with commercialization.

Extension is approved for one year with commercialization from the date of issue of letter of extension.

5.8 Consideration of registration of the product Trichoderma viride 30% LF (Liquid formulation) of M/s Multiplex Biotech Pvt. Ltd., Bangalore.

The Agenda was deliberated in detail and the Committee decided that the applicant’s submission of data received on 25th April 2011 in the CIB&RC may be examined by the Secretariat and complete details may be brought in the next meeting of Registration Committee.

5.9 Registration of Beauveria Bassiana 30% AS of M/s Multiplex Biotech Pvt. Ltd., Bangalore.

The Committee noted the status of application and decided that Show Cause Notice may be issued to the applicant.

6.0 9 (3) Cases 6.1 Consideration of an application of M/s. Syngenta India Ltd.,

Mumbai for grant of registration for import of Mandipropamid Technical u/s 9(3) and Mandipropamid 23.4% SC U/s.9(3).

Approved.

6.2 Status of application of M/s B.M.R. & Co. Pune registration of Neem Oil based formulation containing 0.15% Azadirachtin EC for control of Mosquito larvae u/s 9(3) of the Insecticides Act, 1968.

The Agenda was deliberated in detail and the Committee decided that the applicant may be called in the Secretariat of CIB&RC and deficiencies may be discussed.

7.0

9(4) Cases 7.1

List of applications for registration U/s 9(4).

The Committee deliberated the agenda in detail and approved the applications which are complete from Chemistry angle and for which MRL are fixed/partially fixed/not required ( Reference : list on page 134 to 148 of Agenda)

8.0 Endorsement Cases 8.1 Consideration of expansion of bio-efficacy claims of

Thiamethoxam 30% FS u/s 9(3) of IA 1968 in rice in favour of M/s Syngenta India Ltd., Pune.

Approved.

8.2 Consideration of expansion of bio-efficacy claims of Chlorantraniliprole 0.4% GR u/s 9(3) of IA 1968 in Sugarcane in favour of M/s E.I. DuPont India Pvt. Ltd., Gurgaon.

Approved.

8.3 Consideration of expansion of bio-efficacy claims of Fenpropathrin 30% EC u/s 9(3) of IA 1968 in Rice in Favour of M/s Sumitomo Chemical India Ltd., Mumbai.

Approved.

8.4 Consideration of expansion of bio-efficacy claims of Indoxacarb 15.8% EC u/s 9(3) of IA 1968 in Chickpea in favour of M/s E.I. DuPont India Pvt. Ltd., Gurgaon.

Approved subject to fixation of MRL.

8.5 Check List for Endorsement of name of supplier of already approved source of import in the Certificate of registration.

Approved as per Annexure-II.

8.6 Request of Endorsement of change in company name-request from M/s Sikko Industries Ltd., Ahmedabad-reg.

Approved.

8.7 Application of M/s E.I. DuPont India Pvt. Ltd., Gurgaon for endorsement of additional source of import for product Chlorimuron Ethyl Technical.

The agenda was deliberated in detail and the Committee decided that applicant may be asked to submit the data as per the RC decision in

its 314th meeting of RC vide Agenda Item No.8.3.

9.0 Miscellaneous Items

9.1 Approval of Protocols

9.1(a)

9.1(b)

1. Health monitoring study of Spraymen exposed to Flonicamid 50% WG (field exposure study on human volunteers) submitted by M/s. United Phosphorus Ltd., Mumbai . [F.No.1053-F/9(3)/2010.]

2. Toxicity study to livestock exposed to Flonicamid 50% WG (field exposure study) submitted by M/s. United Phosphorus Ltd., Mumbai. [F.No.1053-F/9(3)/2010.]

The agenda was deliberated in detail and the Committee decided that henceforth data on Health Monitoring Study on Spray Operators and Toxicity to Livestock are not required.

Request for exemption from submitting data on Health Monitoring Studies on Spray Operators and Toxicity to Livestock (Field Trials & Observations) submitted by M/s. Makhteshim-Agan India Pvt. Ltd., Hyderabad.

In view of decision at 9.1(a) request for exemption for data on Health Monitoring Studies on Spray Operators and Toxicity to Livestock are allowed.

9.2 Consideration of application of M/s Bayer CropScience Ltd., for import of sample quantity of BCA-AA10579 Technical for test and trial purpose (RTT).

Approved sample quantity of 12kg.

9.3 Consideration of application of M/s Bayer CropScience Ltd., for import of sample quantity of BCS-AA10579-200 + Iodosulfuron 20 g/l OD (220 OD) for RTT.

Approved sample quantity of 12 litres.

9.4 Consideration of application of M/s Bayer CropScience Ltd., for import of sample quantity of BCS-AA10579-200 + Amidosulfuron 100 g/l OD (300 OD) for test and trial purpose (RTT).

Approved sample quantity of 14 litres.

9.5 Registration of house hold pesticide-request for accepting bio-efficacy data and persistence data generated by SAU and accredited private labs/CRO.

The agenda was deliberated in detail and decided to seek the information from House-hold Pesticides Association about the list of laboratories having the facility for generating bio-efficacy and persistence data for house-hold/public health use pesticides. The Committee further decided that a check-list for infrastructure facilities of laboratories may also be prepared by the Secretariat of CIB&RC.

9.6 Consideration of applications for import permits for Boric acid and other substance for non-insecticidal use.

The Agenda was deliberated in detail and decisions are at Annexure_____ III (Part-I, Part-II & Part-III).

10. Online filing of application for registration under different categories:-

10.1 Summary of disposal of cases including cases being taken up for the approval of Registration Committee.

(a) The Committee deliberated the agenda in detail and approved the applications which are complete from Chemistry angle and for which MRL are fixed, partially fixed or not required. (Reference Agenda Page No. 162 to 170).

(b) Out of List of 71 applications received on-line U/s.9(3) Export Category, 69 applications are approved and application at Sl.No.70 & 71 will be further discussed in next RC meeting. List of 5 applications U/s.9(3) Star Export are approved and Certificate of Registration(CR)

to be issued immediately and in future such cases of Star Export should be brought for post-ex-facto approval as per convention. (Reference Agenda page No.171 to 174).

11.1 Any other item with the Permission of Chair.

(a) Secretariat of CIB&RC may propose the coding of various formulations of bio-pesticides as per the international norms.

(b) Secretariat of CIB&RC may send a copy of certificate of registration to Ministry of Health & Family Welfare while issuing to applicant.

The meeting ended with vote thanks to the Chair.

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Annexure-I.

Check list for submission of application for Attestation of copy of already issued Certificate(s) of Registration

1. Index.

2. Page numbering.

3. Authentication of pages by authorized signatory.

4. Notarized copy of BOD resolution/affidavit/partnership deed.

5. Notarized copy of Certificate(s) of Registration along with labels & leaflets in duplicate. (Second copy may be the photocopy of notarized copy of certificates of Registration duly authenticated by the applicant. Submission of each certificate copy should be indexed with page no.).

6. Affidavit by applicant in the format approved by RC in its 314 th meeting held on 24th & 27th

Jan., 2011.

7. Original Certificate(s) of Registration are to be produced before the designated officer / committee for verification purpose.

Annexure-II

Check List for Endorsement of name of supplier of already approved source of import in the Certificate of Registration. 1. Index

2. Page numbering

3. Notarized copy of BOD Resolution/Affidavit/Partnership Deed

4 Authentication of pages by authorized signatory.

5. Affidavit duly notarized regarding endorsement made earlier in respect of Certificate for which the present request is being made

6. Letter of consent, from approved source of import duly legalized from Indian Embassy/High Commission/ Consulate in the Country of origin.

7 Reference of Registration Committee meeting in which additional source of Import is approved.8. Copy of Registration Certificates along with label/leaflets.

ANNEXURE –III. Part –I.

STATUS OF PENDING APPLICATIONS FOR IMPORT PERMIT OF DUAL USE INSECTICIDES ( BORIC ACID)

S.No Name of the Applicant (M/s) Decision of RC

1 2 3

1. M/s Grauer & Well (India) Ltd., Growel House, 1 st Floor, Akurli Road, Kandivili (E), Mumbai 400 010 lt. NIL. Dt. 8.4.2011.

Approved 150 M.T. of Boric acid taking into account of recommendation of Nodal Agency and annual consumption of preceding years for the two units.

2. M/s Nahar Colours & Coating Ltd., NCCL House G-1,90-93, Sukher Industrial Park, Udaipur – 313 004 Lt. No. NIL dt. 12th April,2011.

Approved 1600 M.T. of Boric acid taking into account of recommendation of Nodal Agency and annual consumption of preceding years.

3. M/s Orient Glazes Ltd., Survey No. 760, Vill. Radhu, Kheda-Dholka Road, Dist. Kheda-387 560, Gujarat letter No. NIL dt. 09-04-2011

Approved 750 M.T. of Boric acid taking into account of recommendation of Nodal Agency and annual consumption of preceding years.

Part –II.

STATUS OF PENDING APPLICATIONS FOR IMPORT PERMIT OF DUAL USE INSECTICIDES

( EXCEPT BORIC ACID)

S.No

Name of the Applicant (M/s) Decision of RC

1 2 3

1. M/s Divi’s Laboratories Ltd., Divi Towers, 7-1-77,E/1/303, Dharam Krand Road, Ameerpet, Hyderabad – 500 016 Lt. No. NIL dated 213.2011

Not approved. The applicant may be asked to clarify regarding the packaging material, storage facilities available with them and mode of transportation etc.

Clarification may be sought from Drug Controller of India, MOH&FW regarding the use of Ethylene dibromide as a raw material for manufacturing drugs as the product is banned for use as insecticide in the country.

2. M/s Divi’s Laboratories Ltd., Divi Towers, 7-1-77,E/1/303, Dharam Krand Road, Ameerpet, Hyderabad – 500 016 Lt. No. NIL dated 213.2011

Not approved. The applicant may be asked to clarify regarding the packaging material, storage facilities available with them and mode of transportation etc.

Clarification may be sought from Drug Controller of India, MOH&FW regarding the use of Ethylene dibromide as a raw material for manufacturing drugs as the product is banned for use as insecticide in the country.

3. M/s Divi’s Laboratories Ltd., Divi Towers, 7-1-77,E/1/303, Dharam Krand Road, Ameerpet, Hyderabad – 500 016 Lt. No. NIL dated 213.2011

Approved 1400 M.T. of Ethylene Dichloride taking into account of recommendation of Nodal Agency and annual consumption of preceding years

4. M/s Divi’s Laboratories Ltd., Divi Towers, 7-1-77,E/1/303, Dharam Krand Road, Ameerpet, Hyderabad – 500 016 Lt. No. NIL dated 213.2011

Approved 140 M.T. of Sodium Cyanide taking into account of recommendation of Nodal Agency and annual consumption of preceding years

5. M/s Excel Industries Ltd., 184-87, Swami Vivekanand Road, Jogeshwari (W), Mumbai – 400 102 Letter No. XL/CIB/IMP/YP/03 dated 28.3.2011

Not approved. The applicant may be asked to inform whether they are authorized/granted permission to import Yellow Phosphorus during the last three year. On which ground they have imported the product.

6. M/s Tamilnadu Petroproducts Ltd., Post Box . 9, Manali Express Highway, Manali, Chennai – 600 068Letter No. NIL dated 22.3.2011

Approved 610 M.T. of Barium Carbonate taking into account of recommendation of Nodal Agency and annual consumption of preceding years.

7. M/s United Phosphorus Ltd., Uniphos House, Madhu Park, 11th Road, Khar (W), Mumbai – 400 052Letter No. NIL dated 5.4.2011

Approved 13000 M.T. of Carbon Disulphide taking into account of recommendation of Nodal Agency and annual consumption of preceding years

8. M/s Laopala RG Ltd., “Chitrakoot”, 10th

Floor, 230A, A.I.C. Bose Road, Kolkata – 700 020 Lt. No. LORG:KOL:2011 dated 28.3.2011

Approved 70 M.T. of Barium Carbonate taking into account of recommendation of Nodal Agency and annual consumption of preceding years.

9. M/s Welsuit Glass & Ceramic Pvt. Ltd., Nr. D.G.S. Gas Station Padra – Jambusar Highway, Opp. Haldyn Glass Gavasad – 391 430 , Tal. Padra Distt. Baroda letter No. NIL dt. 04-04-2011

Approved 200 M.T. of Barium Carbonate taking into account of recommendation of Nodal Agency and annual consumption of preceding years.

Part –III.

Representations for Issuance of Import Permit for Dual Use Insecticides.

S.

No.

Name of the Applicant (M/s) Decision of RC

1 2 3

1. Shri Ashok Desurkar , Merchant Exporter from MumbaiEmail dated 21st March, 2011

The case was deliberated in detail and asked information about :

(i) Registration status for Sodium Cyanide under Insecticides Act, 1968 and; (ii) From where the applicant obtained product for export.

2. M/s M.B. Sales Corporation, 15/17, Khetwadi 8th Lane, Ratnakar - , C.H.S. Ltd., Ground Floor, Mumbai – 400 004Lt. No. NIL dated 8.4.2011

The case was deliberated in detail and decided that the applicant may be called to represent their case before the next RC

3. M/S DCM Shriram Consolidated Ltd., 6th Floor, Kanchenjunga Building, 18, Barakhamba Road, New Delhi – 110001Letter No.SAC/PUR/RM-135 dated 19.4.2011

Not approved. The applicant may be asked to inform:

(i) that they had not utilized the import permit issued earlier vide No. 21-2/2007-CIR.II dated 5.3.2007 for import of 1000 MT of Barium Carbonate with documentary proof from Custom Department, if utilized indicate how much quantity was balanced with them at that time. (ii) Detail from Custom Deptt. regarding the import 1620 MT of Barium Carbonate on the basis of PD bond. The case will be considered after receiving information.

4. M/s Shreeji Impex, 125, C.P. Tank Road, Mumbai – 400 004Lt. No. NIL dated 11.4.2011

The case was deliberated in detail and decided that the applicant may be called to represent their case before the next RC